Droperidol Hikma

PACKAGE LEAFLET

Package leaflet: Information for the user

Droperidolo Hikma 2.5 mg/ml injection solution

Droperidol
Generic medicine
Read this entire leaflet carefully before you start taking this medicine
because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• This medicine has been prescribed for you personally. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Contents of this package leaflet

1. What Droperidolo Hikma is and what it is used for
2. What you need to know before taking Droperidolo Hikma
3. How to use Droperidolo Hikma
4. Possible side effects
5. How to store Droperidolo Hikma
6. Contents of the pack and other information

1. What Droperidolo Hikma is and what it is used for

Droperidolo Hikma is a droperidol injection solution, used in adults, children (from 2 to 11 years of age) and adolescents (from 12 to 18 years of age) to prevent nausea or vomiting during post-operative recovery, or in adults to prevent nausea or vomiting when morphine-based painkillers are administered after surgery.
The active substance of Droperidolo Hikma is droperidol. Droperidol belongs to a group of antipsychotics called butyrophenone derivatives.

2. What you need to know before using Droperidolo Hikma

Do not take Droperidolo Hikma:

• if you are allergic to droperidol or to any of the other excipients of this medicine (listed in section 6).
• if you are allergic to a group of medicines used in the treatment of psychiatric disorders called butyrophenones (e.g. haloperidol, trifluoperazine, benperidone, melperone, domperidone).
• if a member of your family has an abnormal electrocardiogram (ECG) trace.
• if you have low levels of potassium or magnesium in the blood.
• if you have a heart rate lower than 55 beats per minute (your doctor or nurse will check this), or if you are taking other medicines that may cause this effect.
• if you have a tumour of the adrenal gland (pheochromocytoma).
• if you are in a coma.
• if you have Parkinson's disease.
• if you suffer from severe depression.

Warnings and precautions
Before administration of Droperidolo Hikma, inform your doctor or nurse especially if:

• you have epilepsy or a history of epilepsy.
• you have any heart problems or a history of heart problems.
• you have a family history of sudden death.
• you have kidney problems (especially if you are on long-term dialysis).
• you have lung disease or any breathing difficulties.
• you have prolonged nausea or diarrhoea.
• you are taking insulin.
• you are taking potassium-losing diuretics (e.g. furosemide or bendroflumethiazide).
• you are taking laxatives.
• you are taking glucocorticoids (a type of steroid hormone).
• you or someone else in your family has previously had blood clots, as medicines like this have been associated with blood clot formation.
• you are or have been a heavy drinker of alcohol.

Other medicines and Droperidolo Hikma
Inform your doctor or nurse if you are taking or have recently taken any other
medicines.
Do not use Droperidolo Hikma if you are taking any of the following medicines:

During treatment with Droperidolo Hikma, metoclopramide and other neuroleptics should be avoided, as the risk of movement disorders induced by these medicines increases.
Droperidol, the active substance in Droperidolo Hikma, may enhance the effects of sedatives such as barbiturates, benzodiazepines, and morphine-containing products. It may also increase the effects of medicines used to lower high blood pressure (antihypertensives) and of many other medicines, for example certain antifungals, antivirals, and antibiotics. Some medicines may additionally increase the effects of droperidol, for instance cimetidine (for gastric ulcers), ticlopidine (to inhibit blood clotting), and mibefradil (for angina). If you have any doubts, please consult your doctor or nurse.
Droperidolo Hikma with food and alcohol
Avoid consuming alcohol within 24 hours before and after administration of Droperidolo Hikma.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are breastfeeding and need to take Droperidolo Hikma, a single dose of Droperidolo Hikma is recommended. Breastfeeding may be resumed upon awakening after the surgical procedure.
Driving and using machines
Droperidol significantly affects the ability to drive vehicles and use machinery. Do not drive vehicles or operate machinery for at least 24 hours after taking Droperidolo Hikma.

3. How to use Droperidol Hikma

Droperidol Hikma will be administered to you by your doctor as an intravenous injection.
The amount of Droperidol Hikma and the method of administration depend on your condition. Your doctor will determine the dose of Droperidol Hikma you need based on several factors, including weight, age, and medical condition.
The usual dose in adults is 0.625–1.25 mg, reduced to 0.625 mg for elderly patients (over 65 years of age) and those with renal or hepatic impairment. The dosage for children (2–11 years) and adolescents (12–18 years) is based on body weight (10–50 micrograms/kg), but should not exceed a maximum of 1.25 mg.
Droperidol Hikma is not recommended for children under 2 years of age.
If you have any doubts about how to use this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience any increase in body temperature, muscle stiffness, tremor, rapid swelling of the face or throat, or if you have chest pain after taking this medicine.

The following side effects have also been reported. If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor, nurse or pharmacist.

Common side effects (may affect up to 1 in 10 people)

• Drowsiness
• Low blood pressure

Uncommon side effects (may affect up to 1 in 100 people)

• Anxiety
• Eye rolling
• Rapid heart rate (e.g. more than 100 beats per minute)
• Dizziness

Rare side effects (may affect up to 1 in 1,000 people)

• Severe allergic reaction known as anaphylaxis or anaphylactic shock
• Confusion
• Agitation
• Irregular heartbeat
• Skin rash
• Neuroleptic malignant syndrome: Symptoms include fever, sweating, salivation, muscle rigidity, tremors

Very rare side effects (may affect up to 1 in 10,000 people)

• Blood disorders (usually diseases affecting red blood cells or platelets). Your doctor may advise you.
• Mood changes (sadness, anxiety, depression and irritability)
• Involuntary muscle movements
• Seizures or tremors
• Heart attack (cardiac arrest)
• Sudden death
• Torsades de pointes (a life-threatening irregular heartbeat)
• Prolonged QT interval on ECG (a condition affecting the heartbeat)

Other side effects with unknown frequency (frequency cannot be estimated from the available data) that may occur:

• Inappropriate antidiuretic hormone secretion (excessive release of the hormone causing excess water and low sodium levels in the body)
• Hallucinations
• Epileptic seizures
• Parkinson’s disease
• Psychomotor hyperactivity
• Coma
• Loss of consciousness
• Breathing difficulties
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness of the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, seek immediate medical attention.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Droperidolo Hikma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and vial after EXP. The expiry date refers to the last day of the month.
Store in the original packaging.
The solution should be used immediately after first opening.
Compatibility of droperidol with morphine sulfate in 0.9% sodium chloride (14 days at room temperature) has been demonstrated in plastic syringes. From a microbiological standpoint, the diluted product should be used immediately. If not used immediately, the storage time and conditions prior to use are the responsibility of the user and should normally not exceed 24 hours at 2-8°C, unless the dilution has been carried out under controlled and validated aseptic conditions.
Do not use droperidol if you notice any visible signs of deterioration. The product should be inspected visually before use. Only clear solutions free from visible suspended particles should be used.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Droperidolo Hikma contains

• The active substance is droperidol. Each millilitre of solution contains 2.5 mg of droperidol.
• The other ingredients are lactic acid and water for injections.

Description of the appearance of Droperidolo Hikma and contents of the pack
The solution is a clear, colourless solution contained in 2 ml amber glass vials (type I). Each vial contains 1 ml of solution, in packs of 10 or 25 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó, nº8, 8A, 8B, Fervença
2705-906 Terrugem SNT
Portugal

Marketing Authorisation Holder in Italy
Hikma Italia SpA
Viale Certosa 10
27100 Pavia
Italy

This medicinal product is authorised in the European Economic Area countries under the following names:
France Dropéridol Hikma 2.5 mg/1 ml, solution injectable
Germany Droperidol Hikma 2.5 mg/ml Injektionslösung
Italy Droperidolo Hikma
Portugal Droperidol Hikma
United Kingdom Droperidol 2.5 mg/ml Solution for injection
Spain Droperidol Hikma 2.5 mg/ml Solucion inyectable
[To be completed at national level]

The following information is intended for healthcare professionals only:

In addition to the information included in section 3, practical instructions on the
preparation/handling of the medicinal product are provided.
Incompatibilities
Incompatible with barbiturates.
Instructions for use, handling and disposal
For single use only. Any unused solution must be discarded.
The solution should be inspected visually before use. Only clear, colourless solutions free from
visible particles should be used.
For use in PCA: draw droperidol and morphine into a syringe and dilute to volume with 0.9% sodium
chloride for injection.
Any unused medicinal product or waste material must be disposed of in accordance with local legal
requirements.